Several guidance’s, posts, webinars have been published addressing what evidence collection due to the COVID-19 pandemic, and with this Newsletter we are publishing where to find the different national guidelines and recommendations.
Additionally, the MDR Amendment allow us to reconsider our strategies and potential scenarios. In this article I will try and focus on what we can do and how to spend the lock down period and the new situation regarding MDR regarding the collection of clinical evidence.
The COVID-19 pandemic situation has resulted in that the MDR date of application (DoA) is delayed with one year not changing the DoA for IVDR. Both the MDR and the IVDR is challenging many manufacturers with a clinical evidence hurdle, where one of the key important activity concerns assessment or reassessment and updating your device clinical evaluation(s).
The extra year should be used carefully to review again your clinical evaluation reports and update the database searches, the literature and actual report to reflect the new situation. In case that your clinical evidence does not support your safety and performance objectives you have been given now some extra months to collect and process either in a pre- or post-market setting you own clinical data supporting your claims and objectives.
Claims and objectives
Meanwhile updating you Clinical Evaluation it is time to sit with the team sharing all relevant competences and experiences in carefully reviewing the claims and the expected clinical evidence needed to support these claims and the safety and performance objective. When having the overview use your own tools (an example is mentioned below) to specify the activity needed.
Remember there are several active methods available to collect clinical evidence:
- Planned Customer Surveys
- User feedback
- Focus groups
- Experience with similar devices
- Prospective and retrospective Post-Market Clinical Investigations or studies
- Extended clinical investigations
- Company registry based on the output of the risk management file and the CER
- Planned analysis of regional or national device registries – Hospital databases, registries
This can be supplemented by adding data using reactive methods:
- Customer complaints/ incidents
- Non-Conformity Reports and other issues in manufacturing
- Service records
- User Feedback
- Investigator Initiated Studies (IIS)
- Literature review (publication strategy)
- Published data form regional or national device registries
- Expert opinion
Clinical Investigation start-up
If a clinical investigation is needed the startup process to have First Patient First Visit takes up to 3-9 months depending on several factors:
- Complexity of study needed
- Availability of sites
- Regulatory process for the actual sites and study
- Legal process at the actual sites
Although, in the current situation that Ethical Committee & Competent Authority review is expected to take more time than usual due to coronavirus trial priorities and people involved working remotely, situation is normalizing.
If well timed, you will be able to initiate your study kick-off when the pandemic is under control!
Clinical Investigation execution
Most ongoing clinical investigations are put on hold due to the COVID-19 pandemic situation and only coronavirus related trials are being executed. For some investigations physical visits can be converted into a phone or video visit. Monitoring are from the government in most regions also put on hold and no remote monitoring are allowed, not to disturb the hospital staff that in many cases either are reallocated to other activities related to COVID-19 or working home.
In addition, it is time to focus on centralized monitoring, i.e. checking for consistency, data completeness & trends, identification of sites with high (or low for that matter) PD and AE rates getting ready for when the sites are opening again. So, review and internally discuss your study data and follow-up with the concerning sites, if possible, now, or otherwise right after the coronavirus downtime is over, thereby enhancing the quality of your data. You can also perform a TMF reconciliation, making sure all files are in order at sponsor’s as well as site’s end so that the reconciliation shows the files are in order.
There are several activities that should be initiated during this period with less site activities and prepare for the new DoA and possible new scenarios relevant for your companies. You can also use the time for your ongoing clinical investigations to increase the quality of your clinical evidence base, working on your clinical evaluations, clinical study start-up documentation, performing centralized monitoring, and writing clinical study reports and publications where possible.